FDA Orange Book · active-ingredient family
Stiripentol
Stiripentol is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DIACOMIT · NDA 206709
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
4
Exclusivity periods
Brand (NDA) products · capsule, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIACOMITRLD×2 | BIOCODEX SA | NDA 206709 | — | Aug 20, 2018 | |
| DIACOMITRLD×2 | BIOCODEX SA | NDA 207223 | — | Aug 20, 2018 |
Marketing exclusivity (4)
- ODE-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
- ODE-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
- ODE-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
- ODE-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Stiripentol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
